# K101326: NMI IC

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: Sep 2, 2010 after 114 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 36 ancestors in all.
26 later devices descend from it; 3 cite it directly.
3 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070002: Boston Scientific Peripherally Inserted Central Catheter, Boston Scientific (2007) Summary page 1.
- K003839: Central Venous Catheter, Boston Scientific Corp (2001) Summary page 1.
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter, C.R. Bard, Inc. (2007) Summary page 1.
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line, C.R. Bard, Inc. (2005) Summary page 1.
- K061179: Powerhickman Long-Term Intravascular Catheter, C.R. Bard, Inc. (2006) Summary page 2.
- K081113: Cook and Cook Spectrum Central Venous Catheters, Cook, Inc. (2008) Summary page 2.

## Most influential descendants
- K121089: Nmi Picc Iii (2012), 23 descendants of its own
- K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), 14 descendants of its own
- K122882: Nmi Hpicc Iii (2012), 12 descendants of its own
- K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter (2013), 7 descendants of its own
- K133264: Nmi Picc Iii (2013), 6 descendants of its own

## Indications for use
The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.

Source page: https://510kreport.com/device/K101326
Methodology: https://510kreport.com/methodology